MEDRAD CONTINUUM MR INFUSION SYSTEM

K032771 · Medrad, Inc. · FRN · Sep 23, 2003 · General Hospital

Device Facts

• Record ID: K032771
• Device Name: MEDRAD CONTINUUM MR INFUSION SYSTEM
• Applicant: Medrad, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Device Story

Peristaltic infusion pump system; MR-compatible; used in MR environment for maintenance medication/fluid delivery. Input: user-programmed parameters (weight, drug concentration, dose, volume, bolus rate). Operation: microprocessor-controlled peristaltic mechanism; calculates flow rates based on weight-based dosing; provides programmable bolus delivery. Output: controlled fluid infusion. Used by trained medical staff (critical care, ER, radiology nurses). Benefits: enables precise medication delivery during MR procedures without external syringe connections for bolus administration; maintains infusion continuity during patient transport or stationary MR imaging.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design verification of the modified software programming features.

Technological Characteristics

Peristaltic infusion pump; microprocessor-controlled; ABS housing; ultrasonic air-in-line sensor; Li-Ion rechargeable battery. Connectivity: standalone. Sterilization: not specified. Software: modified to include weight-based dose calculation and programmable bolus function; removed intermittent/protocol modes. Accuracy: ± 10%.

Indications for Use

Indicated for patients requiring maintenance medications and fluids during MR procedures; intended for use immediately prior to, during, and after MR procedures; for use by trained medical staff in critical care, ER, or radiology settings.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Medrad Continuum MR Infusion System (K021988)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 2 3 2003

K032771/

## Special 510(k) Summary - Medrad Continuum MR Infusion System

| OFFICIAL CONTACT: | Andrew P. Zeltwanger<br>Regulatory Affairs Analyst<br>Mcdrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] ext. 3005 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Infusion Pump & Accessories [21 CFR 880.5725] |
| COMMON NAME(s): | Peristaltic Pump System |
| PROPRIETARY NAME(s): | Medrad Continuum MR Infusion System |
| PREDICATE DEVICE(s): | Medrad Continuum MR Infusion System<br>(K021988) |
| INTENDED USE: | The Medrad Continuum MR Compatible Infusion<br>System is designed for patients who require<br>maintenance medications and fluids during an MR<br>procedure. It is intended to provide infusion<br>therapy directly prior to, during, and immediately<br>after the MR procedure, functioning while either<br>stationary or mobile. It is not intended to provide<br>long-term patient care outside of the MR<br>environment. The system is to be used by trained<br>medical staff, primarily critical care, emergency<br>room and radiology nursing staff. |

## DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The Medrad Continuum MR Compatible Infusion System has been modified to include two new programming options, and to remove two previous programming options. None of the modifications required changes to the system hardware, labeling, or disposable administration sets. The following two programs have been added as features to the Continuum MR Infusion System:

- 1. Dose Program The Dose Program enables the administration of a weight-based dose in either micrograms/kg/min or milligrams/kg/min. This program is designed for use in procedures that require special dosing and infusion based on the patient's weight. The program calculates a flow rate in ml/hr based on the input parameters programmed by the user. The require parameters are:
- Patient Weight (kg) t
- Drug Concentration (mg/ml) ●
- · Medrad, Inc. · Special 510(k) Device Modification ·
- · Continuum MR Compatible Infusion System ·

{1}------------------------------------------------

- Dose (ug/kg/min or mg/kg/min) ●
- . Volume (ml)
- 2. Bolus Program The Bolus Program chables the Continuum MR Infusion System to administer a bolus to the patient. This program removes the need for an cxternal syringe connection to the Continuum Administration Set for a bolus administration. The Bolus Program feature is available in both the Dose program and the Rate Over Volume mode of the Continuous Program. The Bolus Program prompts the user for the bolus volume and then administers the bolus at the user's command. The following parameters are available for the Bolus Program:
- Bolus Flow Rate (programmable in the Adjust Settings Menu) .
- a. 10 99.9 ml/hr in 0.1 ml increments
- b. 100 500 ml/hr in 1.0 ml increments
- Bolus Volume (0.1 100 ml in 0.1 ml increments) �

In addition to the inclusion of the two programs above, two of the existing programs, the Intermittent Program and the 25-steps Protocol, have been removed from the modified Continuum MR Infusion System.

The following table shows a comparison between the device components of the modified and unmodified Continuum MR Infusion System.

| Parameters | Predicate Device | Modified Device |
|-------------------------------------|------------------------------------------------------------------------------------|--------------------------------------|
| | Medrad Continuum<br>MR Infusion Pump<br>(K021988) | Medrad Continuum MR<br>Infusion Pump |
| Classification | Peristaltic Infusion<br>System | Same |
| Compatible IV Administration<br>Set | Standard PVC<br>Single Use<br>Y Site Set<br>Free Flow Protection | Same Administration Set |
| Flow Rate | 0.1 – 100 ml/hr in 0.1<br>ml increments<br>100 – 500 ml/hr in 1.0<br>ml increments | Same |
| Housing | ABS | Same |
| Microprocessor Controlled | Yes | Same Hardware |
| KVO Infusion Rate | Configurable 1-5 ml/hr | Same |
| System Accuracy | $\pm$ 10% | Same |
| Occlusion Pressure | User Selectable | Same |
| Battery | Li-Ion, Rechargeable | Same Battery |
| Battery Life | 4 hr (at 500 ml/hr) | Same |
| Battery Charging | ~ 6 hr to 95% max.<br>battery capacity | Same |
| Air in Line Detector | User Adjustable | Same |
| Total Time Setting | 100 hours | Same |

· Medrad, Inc. · Special 510(k) Device Modification ·

- · Continuum MR Compatible Infusion System ·

{2}------------------------------------------------

| Air Sensor | Ultrasonic | Same Sensor |
|--------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Bolus Rate | N/A | 10 - 99.9 ml/hr in .1 ml<br>increments<br>100 - 500 ml/hr in 1 ml<br>increments |
| Alarm Conditions | | |
| 1. Air-in-line | 1. Yes | 1. Same |
| 2. Down Occlusion | 2. Yes | 2. Same |
| 3. Pump Unattended | 3. Yes | 3. Same |
| 4. Low Battery | 4. Yes | 4. Same |
| 5. End Battery | 5. Yes | 5. Same |
| 6. Fatal Error | 6. Yes | 6. Same |
| 7. End Program | 7. Yes | 7. Same |
| 8. Missing Key | 8. Yes | 8. Same |
| 9. Lock Mode | 9. Yes | 9. Same |
| Multi-Programs | | |
| 1. Continuous Program | 1. Yes | 1. Same |
| 2. Intermittent Program | 2. Yes | 2. Removed |
| 3. 25-Steps Protocol | 3. Yes | 3. Removed |
| 4. Dose Program | 4. No | 4. Yes |
| 5. Bolus Program | 5. No | 5. Yes |
| Integrated Mounting for IV Pole | Yes | Same |
| Built-in Free Flow Protection | Yes | Same |
| User-selectable Occlusion<br>Pressures | Yes | Same |
| Rate/Volume and Volume/Time<br>Programming | Yes | Same |
| Bolus Capability | Manual, Syringe-<br>induced bolus<br>capability for<br>administration set. | Programmable Bolus<br>Function |
| User Selectable Alarm/Volume | Yes | Same |
| MRI Compatible | Yes | Same |

:

:

.

• Continuum MR Compatible Infusion System •

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Mr. Andrew P. Zeltwanger Regulatory Affairs Analyst Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051-0780

Re: K032771

Trade/Device Name: Medrad Continuum MR Infusion System Regulation Number: 880.5725 Regulation Name: Infusion Pump & Accessories Regulatory Class: II Product Code: FRN Dated: September 4, 2003 Received: September 8, 2003

Dear Mr. Zeltwanger:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{4}------------------------------------------------

Page 2 - Mr. Zeltwanger

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runno

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Intended Use

There has been no change to the indications for use as a result of the proposed modifications described in this submission.

## Indications for Use Statement

2022711 510(k) Number:

Device Name: Medrad Continuum MR Infusion System

Indications for Use:

The Medrad Continuum MR Compatible Infusion System is designed for patients who require maintenance medications and fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during, and immediately after the MR procedure, functioning while either stationary or mobile. It is not intended to provide long-term patient care outside of the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

Patricia Cucurite

Anesthesiology, General Hospital, ontrol, Dental De

510(k) Number. *K032771*

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

Or

Over-the-Counter Use

· Medrad, Inc. · Special 510(k) Device Modification ·

· Continuum MR Compatible Infusion System ·